Medical and safety coverage 24 hours a day, 7 days a week, 365 days a year
Serious Adverse Event/Adverse Event handling
- SAE collection, documentation, review, query and follow-up, processing within the required time frames
Data management
- set up/maintenance of safety database
- SAE/AE logging, tracking, coding
- MedDRA coding
- Generation of CIOMS I/MedWatch forms and line listings
Medical Analysis
- Medical monitoring/review
- AE and SAE evaluation
- SAE narrative writing
- Qualified medical evaluation and assessment
Regulatory reporting
- regulatory reporting to authorities, investigators and Ethics Committees
- electronic safety reporting according to ICH E2B
- Post-marketing: - signal detection, preparation of Periodic Safety Update Reports (PSURs), literature search